Brain Diseases, Cardiovascular Diseases, Central Nervous System Diseases, Nervous System Diseases, Stroke
Conditions
Brief summary
This study will validate a predictive model that uses demographics, functional status, neurophysiology, neuroanatomy, and other potential biomarkers to predict the likelihood of a clinically significant change in impairment at the end of a robot assisted therapy intervention.The study will include magnetic resonance imaging (MRI), transcranial magnetic stimulation (TMS), and an arm exercise program consisting of robot-assisted exercise combined with functional arm exercise called transition to task training (TTT).
Detailed description
After informed consent, a baseline neurological exam, medical records review, MRI of the brain, TMS, questionnaires, cognitive testing, robot evaluations, and arm function testing will occur. Baseline testing will occur in the first 4-6 weeks of participation including two separate sessions approximately 1 week a part to examine arm strength, range of motion, and ability to perform functional tasks, with one additional session if needed to verify stability between results. Additionally, one robot evaluation will be completed. The intervention phase consists of 12 weeks of robot and transition to task arm exercise training (TTT). Interventions will occur approximately 3 times per week for 12 weeks for a total of 36 visits. Additional time and visits will be allowed with visits occurring 4 times per week or up to 6 additional weeks (not to exceed 18 weeks) if scheduling conflicts arise. The intervention sessions will be one hour in duration. During the hour-long intervention, 45 minutes of robotic intervention will be followed by 15 minutes of TTT. The training will be sequential with 12 sessions focused on the wrist, followed by 12 sessions on the shoulder-elbow and the final 12 sessions alternating between the wrist and elbow-shoulder. After the final training session, subjects will return after a 12 week retention period. At various time points during and after the intervention phase there will be additional arm function testing, robot evaluations, questionnaires, MRI and TMS sessions for re-assessment.
Interventions
DEVICERobot + TTT exercise
The intervention will be completed 36 visits approximately 3x/week for 12-18 weeks. The training progression will be sequential with 12 visits completed on the wrist robot, followed by 12 visits on the shoulder-elbow robot and completing with 12 visits alternating sessions on the wrist and shoulder-elbow robot. Participants will perform robot training for 45 minutes with each robot followed by 15 minutes of TTT practice to complete their 60 minute intervention session.
Sponsors
University of Pittsburgh
VA Pittsburgh Healthcare System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
One-arm, multiple baseline sequential, cohort study
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinically defined, unilateral, hemiparetic stroke with radiologic exclusion of other possible diagnosis * Stroke onset at least 6 months before enrollment * Present with Mild/Moderate to Severe arm dysfunction (based on Fugl-Meyer scores of 10 to 45) * Be medically stable to participate in the study * Be English speaking
Exclusion criteria
* Unable to give informed consent * Have a serious complicating medical illness that would preclude participation. * Contractures or orthopedic problems limiting range of joint motion in the potential study arm * Visual loss such that the subject would not be able to see the test patterns on the robot computer monitor * Botulinum toxin to study arm within four months of study enrollment or if received during the study period * Unable to comply with requirements of the study * Participants with a history of a seizure will not be precluded from the study, but will not be enrolled in the TMS portions * Participants with electromagnetic exclusions (metal implants in the cranium, implanted electronic devices etc.) will not be precluded from the study but will be excluded from the MRI and TMS portions * Have a serious complicating medical illness that would preclude participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A Change in the Fugl-Meyer Upper Extremity Assessment Score | Immediately following the 12-week intervention | The Fugl-Meyer is one of the primary outcome measures assessing change in arm use from baseline testing to mid-training after visits 12 and 24, and post-training after visit 36 and the 12 week retention period. It is a stroke-specific measure of impairment of the upper extremity that has been shown to be valid and reliable with high inter-rater and test-retest reliability. It provides a direct-observational assessment of volitional movement and motor impairment related to reflexes, sensation, and abnormal synergies. Each item on the FM is rated on a three-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully). The scale ranges from 0-66 with higher scores representing less motor impairment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| A Change in Motor Evoked Potential During Transcranial Magnetic Stimulation of the Motor Cortex | Immediately following the 12-week intervention | TMS stimulation of the motor cortex will be performed using MagStim 200 Magnetic Stimulators (MagStim Ltd., Wales, UK) to assess change in the motor evoked potential (MEP) of the arm muscles. |
| A Change in Brain Connections Assessed Via MRI of the Brain | Immediately following the 12-week intervention | A detailed analysis of the MRI data will examine individual interregional connections to determine whether any of them are more sensitive to the intervention than others. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Robot + TTT Exercise All participants will be enrolled in this group to receive the same 60 minute study intervention consisting of wrist and shoulder-elbow robot training and TTT arm exercises.
Robot + TTT exercise: The intervention will be completed 36 visits approximately 3x/week for 12-18 weeks. The training progression will be sequential with 12 visits completed on the wrist robot, followed by 12 visits on the shoulder-elbow robot and completing with 12 visits alternating sessions on the wrist and shoulder-elbow robot. Participants will perform robot training for 45 minutes with each robot followed by 15 minutes of TTT practice to complete their 60 minute intervention session. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Robot + TTT Exercise |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
A Change in the Fugl-Meyer Upper Extremity Assessment Score
The Fugl-Meyer is one of the primary outcome measures assessing change in arm use from baseline testing to mid-training after visits 12 and 24, and post-training after visit 36 and the 12 week retention period. It is a stroke-specific measure of impairment of the upper extremity that has been shown to be valid and reliable with high inter-rater and test-retest reliability. It provides a direct-observational assessment of volitional movement and motor impairment related to reflexes, sensation, and abnormal synergies. Each item on the FM is rated on a three-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully). The scale ranges from 0-66 with higher scores representing less motor impairment.
Time frame: Immediately following the 12-week intervention
Population: Only one subject was enrolled and data collection was incomplete due to the Covid-19 pandemic. The evaluations following the 12-week intervention were not performed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Robot + TTT Exercise | A Change in the Fugl-Meyer Upper Extremity Assessment Score | Baseline One | 11 units on a scale |
| Robot + TTT Exercise | A Change in the Fugl-Meyer Upper Extremity Assessment Score | Baseline Two | 12 units on a scale |
| Robot + TTT Exercise | A Change in the Fugl-Meyer Upper Extremity Assessment Score | After Visit 12 | 13 units on a scale |
| Robot + TTT Exercise | A Change in the Fugl-Meyer Upper Extremity Assessment Score | After Visit 24 | 14 units on a scale |
Other Pre-specified
A Change in Brain Connections Assessed Via MRI of the Brain
A detailed analysis of the MRI data will examine individual interregional connections to determine whether any of them are more sensitive to the intervention than others.
Time frame: Immediately following the 12-week intervention
Population: MRI was not collected as the one enrolled subject did not pass the MRI safety screening.
Other Pre-specified
A Change in Motor Evoked Potential During Transcranial Magnetic Stimulation of the Motor Cortex
TMS stimulation of the motor cortex will be performed using MagStim 200 Magnetic Stimulators (MagStim Ltd., Wales, UK) to assess change in the motor evoked potential (MEP) of the arm muscles.
Time frame: Immediately following the 12-week intervention
Population: Only one subject was enrolled and data collection was incomplete due to the Covid-19 pandemic. The evaluations (including TMS) following the 12-week intervention were not performed.